What is the Difference Between GLP GMP requirements in Laboratory Studies?
When it comes to the manufacturing of pharmaceutical and cosmetic products, there are many standards and procedures to be followed. In fact, in the life sciences industry, every step of the product research, development, and production cycle has a series of Good Practices or GxP standards that must be followed closely/strictly.
Two of such studies that are very important in most manufacturing processes are Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Both these processes are employed at different stages of the product development and manufacturing series. Before discussing the differences between the two, it is important to understand what GLP and GMP mean and where they are applicable.
What is GLP?
As evident from the name, GLP is focused on laboratory-based operations like research and study. In broader terms, Good Laboratory Practices can be defined as monitoring the conditions and processes performed in a laboratory. This is followed by accurate documentation and archiving of the study data, which is crucial to support and advertise the end product.
What is GMP?
GMP or Good Manufacturing Practices are associated with quality assurance during the manufacturing of a product. They are implemented to make sure that the products are manufactured under the best conditions and have guidelines regarding material hygiene, storage, maintenance, and other things related to the final product.
Difference Between GLP GMP Requirements
After understanding what GLP GMP requirements are, where and how they must be followed, we are going to differentiate GLP and GMP processes based on ten criteria. These will help you differentiate both the practices and also understand both of them in a little more detail.
1. Study Director
The appointment of a study director is one of the prominent points of difference between GLP GMP requirements. In GLP regulations, a single person, or point of contact is responsible for the complete study. The same person is accountable for the control and management of the entire study, whereas, under GMP, there is no such requirement of assigning a study director.
2. Quality Units
GLP has a quality assurance unit that is assigned the job of inspecting the study during all its important phases. Along with that, this unit also inspects the facility to check the integrity and compliances of the study being conducted. In contrast, GMP has the Quality Control Unit whose responsibility is to review and approve or reject all the reports generated from the manufacturing procedures. Sometimes GMP also has a quality assurance unit that works in ways similar to a GLP.
3. Testing Facility Management
Another major difference between GLP GMP requirements is the management of the testing facility. As per GLP, it oversees the designation of a study director who has all the appropriate education and training. It also has to make sure that there is separate quality assurance staff and comply with personnel, equipment, and facility requirements. As per GMP, testing facility management is responsible for personnel training. Another important duty is to provide written rules and procedures and ensure that they are being followed properly.
4. Types of Testing
In GLP, an open-ended determination of product is performed to obtain reports and results that are later submitted to the regulatory authorities for pre-market approval. When it comes to the types of testing as per GMP, the main criteria are that the samples and products manufactured should meet the specifications and standards set.
5. Facility
When it comes to the facility, both GLP GMP requirements should have a facility design and construction suitable for all the different types of testing conducted. Separation of areas to stop mix-ups and contaminations is a must. The main difference is in regards to the lighting, plumbing, washing, and sewage facilities. GLP does not mention any of these, but GMP, on the other hand, has specific requirements for these.
6. Equipment
Equipment is another criteria where GLP GMP requirements are different. In GLP, the equipment is allocated and maintained properly, and their condition is constantly recorded to allow study re-constructability. Also, data-generating equipment is calibrated to maintain the integrity of the data. Under GMP, all the equipment used must be eligible for use in the manufacturing process. Calibrated data generated equipment is used for product testing. Proper documentation of test methods accuracy, sensitivity, and reproducibility is documented.
7. Standard Operating Procedure
Under both GLP GMP requirements, these are written procedures that are drafted by qualified personnel. For GLP, a person approved by the testing facility management records the study objective and methods of conduct separately for every study and must be approved by the study sponsor and study director before initiation. Under GMP, however, study-specific protocols are required. Only the standard written procedures are followed.
8. Master Schedule
Under GLP, an index of all the studies conducted is maintained by the quality assurance unit. However, in GMP, there is no such requirement.
9. Records and Reports
Another critical difference between the two regulations is the GLP GMP requirement relating to records maintenance. Under GLP, all records kept must be dated along with signatures or initials of all the staff personals that execute the preparation and procedure. These records must be safely preserved for a minimum of 2 years period and up to 5 years if the product applies for a market permit. As per GMP, records having signatures of all the personal, both staff and the verification supervisors, should be maintained for at least a minimum of one year after the expiry of the product.
10. CAPA System
Under GLP regulations, there is no requirement of having a CAPA system, whereas, under GMP, it is required.
After reading this article, you’ll be able to understand the major differences between GLP and GMP. Not only are these two completely different processes but also have different applications in the product development and manufacturing cycle. Some products do not have GLP GMP requirements, but these always provide accurate and reliable results that are easy to review the final product. But anyone having a good grasp of business and strong intuition will easily understand the importance of these compliances.